Cpl, in partnership with our client Pfizer, are currently recruiting for a QC Analyst - Potency/Cell Culture to work on site in their Biologics facility in Grange Castle, Dublin West.
- Contribute to the operation of QC Laboratories.
- Follow and assist in the creation, review and maintenance of SOP’s for cGMP lab test procedures and systems.
- Facilitate and assist with laboratory investigations.
- Facilitate and assist with corrective action tasks.
- Ensure safe operations, attention to detail and good documentation skills according to cGMP.
- Perform routine Potency/Cell Culture Tasks including but not limited to.
- Performing cell based assays such as cell proliferation and apoptosis assays to support release and stability testing.
- Performing In Vitro Relative Antigenicity Assays to support release and stability testing.
- Preparation and Qualification of Critical Reagents.
- Review of lab testing results.
- Media preparation and reagent qualification
- Establish and Maintenance of Cell Line folders
- Cell Banking and Qualification
- Cell Revival
- Cell Passaging of both adherent and suspension cell lines
- Cell Counting
- Waste inactivation
- Assist in the running of the Potency/Cell Culture lab including weekly ROTA preparation, inventory checks, expiry checks, logbook review, waste maintenance and consumables and stock checks
- Support the management of contract lab testing.
- Support and assist in the introduction of new Cell Lines
- Support the creation of new LIMS builds for new Cell Lines/Assays
- Ensure supply of cells and other critical reagents to external labs as required
- Assist in the maintenance and development of training programs and perform training of other analysts
- Maintain established 5S process and assist in the 5S audits and related activities
- Support and assist the continuous improvement projects and all related CI activities
- Perform and assist in additional duties as directed by the Supervisor.
- Report and document any non-conformances to the Supervisor.
The ideal candidate will hold a bachelors degree in a suitable Science/Biology subject as well as some practical experience working with potency testing/cell culture in a laboratory environment.